C.L.A.I.M.S. Private Limited
Mumbai, India
NCT Number: NCT07493850
The goal of this clinical study is to evaluate the efficacy and tolerability of EMC-CAP-2025A, an eggshell membrane-based dietary supplement, on age-related skin parameters in healthy adults.
The main questions this study aims to answer are:
* Does daily supplementation with EMC-CAP-2025A improve facial wrinkles compared to placebo? * Does EMC-CAP-2025A improve skin hydration, firmness, elasticity, texture, and overall skin quality? * Is EMC-CAP-2025A well tolerated when taken daily for 60 days?
Researchers will compare EMC-CAP-2025A to a placebo to assess its effects on multiple skin parameters using objective instrumental assessments and participant self-evaluations.
Participants will:
* Be randomly assigned to receive either EMC-CAP-2025A or a placebo * Take one capsule orally once daily for 60 days * Attend scheduled study visits at baseline, Day 30, and Day 60 for instrumental skin assessments and safety evaluations * Complete self-assessment questionnaires related to skin quality and product tolerability
This study is active but is not currently recruiting participants.
Notify Me30 year–55 year
All sexes
Interventional
Phase 2
Mumbai, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EMC-CAP-2025A 300 mg per capsule Regimen: 1 capsule per day after meals Route: Oral Duration: 60 days
Placebo
Time frame: Day 0 to Day 60
Wrinkles [average wrinkle length, average wrinkle area, average wrinkle volume, average wrinkle count] measurement using 3D imaging.
Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)
Time frame: Day 0, Day 30 and Day 60
The MoistureMeter SC measures the hydration of the skin surface, the stratum corneum. The skin is an electrically layered structure. The electrical properties of its layers are related to their water content. The probe, the skin surface and the deeper skin layers form a structure, like an electrical capacitor. The measured capacitance is proportional to the water content of the surface layer of the skin. The higher the reading, the higher the moisture content.
Instrument: MoistureMeter SC Compact (Delfin Technologies, Kuopio, Finland)
Time frame: Day 0, Day 30 and Day 60
The Cutometer is a measuring device that helps to estimate the degree of firmness and elasticity of the skin using negative pressure, which deforms the skin mechanically.
The measuring principle is based on the suction method. Negative pressure is created in the device, and the skin is drawn into the aperture of the probe and after a defined time released again. The resistance of the skin to the negative pressure gives the skin firmness and its ability to return to its original position gives the elasticity of the skin.
Cutometric measurements are carried out on the cheeks. The following parameters will be analyzed for this study. Readings will be taken at all visits.
Time frame: Day 0, Day 30 and Day 60
Hyperpigmentation spots (blemish, post-inflammatory hyperpigmentation, acne marks, age spots, sunspots)-[mean pigmentation, mean L*] measurement using 3D imaging.
Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)
Time frame: Day 0, Day 30 and Day 60
Average pore volume and porosity index measurement using 3D imaging.
The Optical 3D is a camera for image acquisition and analysis of the skin. It relies on multi-directional illumination and computer-aided reconstruction of the skin surface, illuminating the surface from different angles and using the differences between these images to reconstruct the surface in three dimensions. The skin topography and the chromophores concentration are derived from the spatial and spectral analysis of the acquired image data, obtained by illuminating the skin with light emitting diodes (LEDs) of different wavelengths (455 to 625 nm) shining from different directions. The surface reconstructed in this way is then used for quantitative skin analysis.
Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)
Time frame: Day 0, Day 30 and Day 60
Skin roughness measurement using 3D imaging. The Optical 3D is a camera for image acquisition and analysis of the skin. It relies on multi-directional illumination and computer-aided reconstruction of the skin surface, illuminating the surface from different angles and using the differences between these images to reconstruct the surface in three dimensions. The skin topography and the chromophores concentration are derived from the spatial and spectral analysis of the acquired image data, obtained by illuminating the skin with light emitting diodes (LEDs) of different wavelengths (455 to 625 nm) shining from different directions. The surface reconstructed in this way is then used for quantitative skin analysis.
Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)
Time frame: Day 0, Day 30 and Day 60
The Allergan Skin Roughness Scale is a validated, 5-point photo-numeric scale used by clinicians to visually assess the texture of facial skin, particularly in the midface area. It grades skin roughness from 0 (smooth) to 4 (extremely coarse), using a set of images and detailed descriptors to provide objective, consistent, and reliable assessments.
Time frame: Day 0, Day 30 and Day 60
A subjective self-assessment questionnaire will be administered to participants to understand participant perception of efficacy of the product.
Time frame: Day 60
Self-assessment questionnaire for in-use tolerance to capture any systemic side effects.
Circul'Egg
Industry
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of EMC-CAP-2025A on Age-Related Skin Parameters in Healthy Individuals
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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